K240257
- 510(k) number
- K240257
- Device name
- Denali Vena Cava Filter System Femoral and Jugular/Subclavian Delivery Kit
- Applicant
- Bd AL · US
- Product code
- DTK — Filter, Intravascular, Cardiovascular
- Decision date
- 2024-02-29
- Date received
- 2024-01-31
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K240257.pdf
Official FDA record: K240257
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.